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WO2021113970A1 - Systèmes de redirection de cathéter destinés à être utilisés pour accéder à des artères cérébrales - Google Patents

Systèmes de redirection de cathéter destinés à être utilisés pour accéder à des artères cérébrales Download PDF

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Publication number
WO2021113970A1
WO2021113970A1 PCT/CA2020/051695 CA2020051695W WO2021113970A1 WO 2021113970 A1 WO2021113970 A1 WO 2021113970A1 CA 2020051695 W CA2020051695 W CA 2020051695W WO 2021113970 A1 WO2021113970 A1 WO 2021113970A1
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WO
WIPO (PCT)
Prior art keywords
distal tip
cerebral artery
clot
distal
catheter
Prior art date
Application number
PCT/CA2020/051695
Other languages
English (en)
Inventor
Mayank GOYAL
Original Assignee
Mg Stroke Analytics Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mg Stroke Analytics Inc. filed Critical Mg Stroke Analytics Inc.
Priority to US17/293,027 priority Critical patent/US12194252B2/en
Publication of WO2021113970A1 publication Critical patent/WO2021113970A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22031—Gripping instruments, e.g. forceps, for removing or smashing calculi
    • A61B2017/22034—Gripping instruments, e.g. forceps, for removing or smashing calculi for gripping the obstruction or the tissue part from inside
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22094—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for crossing total occlusions, i.e. piercing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2212—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having a closed distal end, e.g. a loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/06—Head
    • A61M2210/0693—Brain, cerebrum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system

Definitions

  • the invention describes catheter systems and methods for accessing the brain during endovascular/neurointervention procedures in the treatment of ischemic stroke. More specifically, systems enabling improved control of a catheter through cerebral vessels are described that improve the process of accessing a clot in a patient with acute ischemic stroke due to large vessel occlusion.
  • the human body is an extensive network of blood vessels including the venous and arterial systems for circulating blood throughout the body.
  • the occurrence and/or development of restrictions to flow within the circulatory system can result in serious medical conditions, the most significant being myocardial infarction and ischemic stroke.
  • the treatment of both conditions (and others involving the circulatory system) continues to evolve with many new techniques and equipment being utilized to effect treatment.
  • ischemic strokes caused by blood clot blockages in the brain may be treated by advancing catheter systems to the affected site whence various procedures can be initiated to treat the problem.
  • Known techniques include the deployment of various designs of catheters singularly and/or in conjunction with other catheters/stents to gain access to and remove the clot.
  • the penumbra is tissue around the ischemic event that can potentially stay alive for several hours after the event by the perfusion of this tissue by collateral arteries.
  • the collateral arteries may provide sufficient oxygen, nutrients and/or flushing to the penumbra tissue to prevent this tissue from dying for a period of time.
  • endovascular treatment of acute ischemic stroke due to large vessel occlusion in the anterior circulation is now the standard of care for patients under certain criteria. That is, patients exhibiting particular symptoms (i.e stroke symptoms of a particular severity) will benefit from early and rapid endovascular intervention to open occluded blood vessels.
  • an interventionist will advance a series of catheters from the patient’s groin through the femoral artery, descending aortic artery, to the aortic arch and into the cervical and cerebral arterial system towards the clot. After access to the clot is achieved by placement of the catheters, clot- retrieval and/or clot-suction devices are deployed through the catheter where the clot is either withdrawn and/or aspirated from the clot site.
  • MCA middle cerebral artery
  • Recanalization procedures utilize a wide range of equipment and techniques to access a clot and effect its removal.
  • the endovascular surgeon will have several tools at their disposal including a wide range of guide catheters, balloon guide catheters, diagnostic catheters, microcatheters, microwires, stents and other tools that individually have properties, features and functions that are effective for different procedures and patient presentations.
  • Most, if not all, of the above tools are disposable and they are also expensive.
  • a smaller number of tools and/or at a lower cost there is a motivation to continue to design new tools that can achieve these objectives.
  • these procedures are performed by gaining access to the arterial vascular system through the patient’s groin area by puncturing the common femoral artery. An arterial sheath is inserted.
  • a catheter system (usually a co-axial system including a guide catheter or balloon guide catheter and diagnostic catheter) is advanced through the descending aorta to reach the aortic arch.
  • the diagnostic catheter is shaped and is used to hook the vessel of interest and with the help of a guidewire, the diagnostic catheter is advanced to the relevant carotid artery. Subsequently the guide catheter/balloon guide catheter) is advanced over the diagnostic catheter such that the tip is in the relevant internal carotid artery.
  • catheters that are designed for intracranial access are advanced through the guide catheter.
  • This will typically consist of one of two approaches: a. a microcatheter and a microwire; or, b. a tri-axial system comprising of a distal access catheter (DAC), a microcatheter and a microwire.
  • DAC distal access catheter
  • the DAC is placed proximal to the clot.
  • the microcatheter is used to cross the clot and after removal of the microwire, a stent retriever is deployed. Then the stent-retriever and DAC are typically withdrawn together, while aspirating from the DAC.
  • a stent retriever is not used and directly an attempt is made to capture the clot by aspirating through the DAC.
  • Diagnostic catheters are generally those used to gain access to an area of interest whereas guiding catheters are used to support and guide additional equipment including diagnostic catheters, guidewires, balloons, other catheters etc. as may be required for a particular surgical technique.
  • Typical diagnostic catheters will range from 4F to 6F (French) and have lengths of 65- 125cm. They may have braided wall structures and they will generally have a soft tip with a range of shapes formed into the tip.
  • Guide catheters are generally larger (e.g. 6-8F) and are 80-100cm in length. They generally have reinforced construction with a significantly stiffer shaft to provide back-up (i.e. retro) support for the advancement of any additional equipment as listed above. However, guide catheters can generally only be advanced as far as the carotid artery in the neck in that the combination of their stiffness, the narrowing of vessels and the curvature of vessels prevents further advancement.
  • catheters generally pass through different zones of the vasculature, namely the abdominal and thoracic vasculature between the femoral artery and aortic arch (approximately 50-75cm), the cervical vasculature (approximately 15- 20 cm) and the cephalic/cerebral vasculature (approximately 10-15 cm).
  • the vessels progressively narrow from 2 cm in the aorta down to 3 mm and smaller in the cerebral vessels.
  • Pushability the ability to advance the tip or head of the catheter based on the input from the operator from the hub (i.e. from outside the body).
  • a diagnostic catheter may have a flush, straight, simple curve, complex curve, reverse curve or double curve shapes inter alia. Such shapes may be categorized as simple or complex.
  • Stiffness the ability of a catheter to bend around a curve and support a catheter moving within it.
  • diagnostic catheters are provided with a wide range of tips having the above shapes to allow the interventionist a choice of tip shape when conducting a procedure mainly to address variations in a patient’s anatomy.
  • Each catheter may be constructed from a plurality of materials, having various structures and/or layers within the catheter wall structure to give the catheter particular properties or functional characteristics. These may include:
  • Surface Coatings -Surface coatings desirably reduce thrombogenicity, have low friction coefficients and/or anti-microbial characteristics.
  • Polymer Layers -Different polymers may be used to give different structural characteristics to the body of the catheter.
  • o Polyurethanes can be soft and pliable and hence follow guide wires more effectively. However, they have a higher coefficient of friction.
  • o Nylon may be used for stiffness and be able to tolerate higher flow rates of fluids through them.
  • a sheath is deployed.
  • the sheath acts as an access port to the body and will be inserted about 5cm of a typical 15cm length into the femoral artery.
  • the sheath has an ID of approximately 8F.
  • GC guide catheter
  • BGC balloon guide catheter
  • DC diagnostic catheter
  • GW guide wire
  • the DC is manipulated to gain access to the desired carotid artery.
  • the GW After gaining access to the carotid artery, the GW is advanced, typically up to 20-30cm towards the occlusion site (but within the cervical carotid arteries). • After the GW has been advanced (or concurrently and/or sequentially), the DC is advanced over the GW to gain access to the occlusion site. This may occur in a concurrent and/or sequential process depending on the particulars of a particular patient. However, this step can have significant problems.
  • the design of the DC is to enable hooking the relevant vessel. Typically, the tip (distal 5 cm) is pre-shaped and overall the diagnostic catheter is stiff and torquable.
  • the GC/BGC is advanced over the DC and GW to also gain access to a straight segment of the cervical internal carotid artery.
  • a microcatheter (MC) and microwire (MW) are advanced together through the BGC all the way to the clot such that the distal tip of the MC and MW are positioned just past the distal edge of the clot.
  • a MC as described in Applicant’s copending application US 14/809,867 and incorporated herein by reference, may be used to effect movement through these arterial systems.
  • a stent i.e. clot retrieval device
  • a stent is advanced through the MC until the distal tip of the stent is adjacent the distal end of the MC.
  • the BGC is inflated to stop antegrade flow and retrograde flow (suction) through the BGC is initiated.
  • DAC distal access catheter
  • the guide catheter which is not a BGC (i.e. a DAC) is placed in the cervical internal carotid artery.
  • the DC is removed iii.
  • a tri-axial system consisting of a DAC, a MC and MW are advanced towards the intracranial circulation with the aim of having the tip of the DAC (Aspiration catheter) reach the face of the clot.
  • the MC and MW may have to be placed beyond the clot.
  • the DAC will have a maximum size of 6F.
  • the MW is removed and a stent is deployed across the clot. iii. Then, while applying suction to the DAC, the MC and stent are withdrawn. Thus, the suction pressure is right next to the clot rather than from the neck as with a BGC. Also, the stent enters the DAC while still in the intracranial vessels thus reducing the likelihood of losing the clot once it has been captured.
  • a GW, MC and stent may be subsequently deployed.
  • BGCs are used to enable the surgeon to stop antegrade blood flow and are necessary to minimize the risk in cases where the DAC is being withdrawn with a partially-ingested clot for the clot to shear and embolize distally. That is, as the diameter of the clot (and stent if being used) can be larger than the inner lumen of the BGC, as the DAC is being withdrawn (with or without the stent), there is a significant chance of part of the clot being sheared off and embolizing distally. Hence cessation of antegrade flow by inflating the balloon reduces the risk of this happening.
  • the use of a BGC reduces the size of the DAC as the DAC must be within the BGC.
  • advancing a single large ID/OD catheter from the groin (or other access point) to the clot without using a BGC is desirable. More specifically, it is desirable to position a larger catheter having larger distal opening deeper in the brain to:
  • a further problem can occur when a clot is located at or near a vessel bifurcation and alignment of an aspiration catheter with the clot is more difficult.
  • the invention provides a method for advancing an aspiration catheter (AC) through a tortuous section of a cerebral artery, particularly when the AC has become stuck within the tortuous section, the method comprising the steps of: a) conveying a redirection device (RD) operatively retained within a microcatheter (MC) through the AC to a distal tip of the AC, the MS having a push wire (PW) operatively connected to a proximal end of the RD wherein the RD is expandable relative to the size of the MC; b) conveying the MC and RD to a position beyond the distal tip of the AC; c) withdrawing the MC relative to the RD so as to cause a distal tip of the MS to emerge from the MC and expand to engage with an inner wall of the cerebral artery and the distal tip of the AC and wherein contact of the RD with both the cerebral artery and AC relieves pressure on the distal tip of the AC preventing forward
  • the method may also include steps of re-sheathing the RD within the MC; and, withdrawing the RD and MC from the AC.
  • the method may also include advancing a MC operatively containing a microwire (MW) within the AC to provide support to the AC for further advancement of the AC within the cerebral artery.
  • MW microwire
  • the invention provides a method for advancing an aspiration catheter (AC) through a tortuous section of a cerebral artery, particularly when the AC has become stuck within the tortuous section, the method comprising the steps of: a) conveying a redirection device (RD) operatively retained within the AC to a distal tip of the AC, the RD having a push wire (PW) operatively connected to a proximal end of the RD wherein the RD is expandable relative to the size of the AC; b) pushing the RD to a position beyond the distal tip of the AC so as to cause a distal tip of the RD to emerge from the AC and expand to engage with an inner wall of the cerebral artery and the distal tip of the AC and wherein contact of the RD with both the cerebral artery and AC relieves pressure on the distal tip of the AC preventing forward move of the AC; and, c) when pressure has been relieved and/or when the AC has been re-aligned within the cerebral
  • the invention provides a system for relieving pressure and re aligning an aspiration catheter (AC) in contact with a cerebral artery, particularly within a tortuous section of the cerebral artery comprising: a redirection device (RD) operatively contained within a microcatheter, the RD expandable and having a microwire (MW) operatively connected to a proximal end of the RD wherein the RD is deployable and re- sheathable from a distal tip of the MC and wherein upon deployment the RD is expandable to engage with an inner wall of the cerebral artery and a distal tip of the AC to relieve contact pressure between the AC and cerebral artery and/or re-align the AC within the cerebral artery.
  • RD redirection device
  • MW microwire
  • the RD may be self-expanding or be manually expandable and compressible.
  • the system includes a first MW fixed to a proximal end of the RD and a second MW fixed to a distal end of the RD, the second MW being telescopically retained within the RD and where movement of the first MW relative to the second MW causes shortening or lengthening of the RD to cause expansion and compression of the RD respectively.
  • a first MW is operatively connected to a proximal end of the RD and a second MW is telescopically retained within the RD and is operatively engageable with a distal tip of the RD and where movement of the first MW relative to the second MW causes a shortening or lengthening of a distance between the proximal and distal ends of the RD and causes an expansion or compression respectively of a diameter of the RD.
  • the second MW can be advanced and torqued relative to the RD and the second MW includes a DES distal to the MW, the DES engageable with the distal end of the RD.
  • the second MW includes a distal tip portion distal to the RD.
  • the invention provides a system for relieving pressure and re aligning an aspiration catheter (AC) in contact with a cerebral artery, particularly within a tortuous section of the cerebral artery comprising: a redirection device (RD) operatively contained within a microcatheter, the RD self-expanding and having a microwire (MW) operatively connected to a proximal end of the RD wherein the RD is deployable and re- sheathable from a distal tip of the MC and wherein upon deployment the RD expands to engage with an inner wall of the cerebral artery and a distal tip of the AC to relieve contact pressure between the AC and cerebral artery and/or re-align the AC with the cerebral artery.
  • RD redirection device
  • MW microwire
  • the invention provides a method for redirecting and advancing an aspiration catheter (AC) past a cerebral artery at a bifurcation and retrieving a clot adjacent the bifurcation, the method comprising the steps of: conveying a redirection device (RD) operatively retained within a microcatheter (MC) through the AC to a distal tip of the AC, the RD having a push wire (PW) operatively connected to a proximal end of the RD wherein the RD is expandable relative to the size of the MC; conveying the MC and RD to a position beyond the distal tip of the AC and past a distal edge of the clot; withdrawing the MC relative to the RD to cause a distal tip of the RD to emerge from the MC and expand to engage with the clot and the distal tip of the AC and wherein contact of the RD with the AC relieves pressure on the distal tip of the AC preventing forward movement of the AC; when
  • FIG. 1A is a schematic diagram of a region of the cerebral vasculature showing a clot Y distal to a tortuous section of the vasculature.
  • Figure 1A(1) is a schematic diagram of a region of the cerebral vasculature showing a clot Y adjacent a bifurcation.
  • Figures 1B to 1G illustrate procedural steps of navigating a G2B/AC catheter through a tortuous section after the G2B/AC catheter has become stuck at S including as the G2B/AC becomes stuck ( Figure 1 B), positioning a redirection device (RD) ( Figure 1C), deploying a RD ( Figure 1D), advancing the G2B/AC past the position S ( Figure 1E), re-sheathing the RD ( Figure 1F) and continuing progression of the G2B/AC ( Figure 1G).
  • RD redirection device
  • Figures 2A, 2B and 2C are side and cross-sectional sketches showing details of a process by which pressure is relieved during advancement of a G2B/AC.
  • Figures 3A-3F are sketches showing the process of advancing a G2B/AC utilizing a RD in accordance with one embodiment of the invention.
  • Figure 4A and 4B are sketches showing a manually expandable and compressible RD in accordance with one embodiment of the invention.
  • Figures 5A-5D are sketches showing the deployment of an RD at a vessel bifurcation where a clot is located partially within one arm.
  • the inventor who has experience in the treatment of acute ischemic stroke recognized that a problem exists in moving larger diameter aspiration catheters through the cerebral vasculature and in particular the problem of such catheters getting stuck within the cerebral arteries during advancement of the catheter towards a clot.
  • the invention as described herein describes procedures and systems for relieving pressure on a stuck aspiration catheter and otherwise re-aligning the catheter within an artery to enable it to be advanced further during endovascular/neuro-intervention procedures. . Scope of Language
  • spatially relative terms such as “distal”, “proximal”, “forward”, “rearward”, “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a feature in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under.
  • a feature may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
  • Figure 1A shows a schematic section of the cerebral arteries where access to a blood clot Y is required distal to a tortuous section of the vasculature.
  • the clot Y is located in a location distal to the ophthalmic artery which is typically a location that is difficult to negotiate with larger catheters, particularly in older patients.
  • catheters designed to extend from the access position can be used as aspiration catheters if they can be advanced sufficiently close to the clot to enable aspiration.
  • catheters after gaining access to the carotid arteries, are advanced via progressive advancement of a microwire MW and microcatheter MC followed by the larger catheter that is to be used for aspiration.
  • This larger catheter is referred to as either a G2B (groin to brain) catheter to utilize consistency with terminology used in other applications and also an aspiration catheter (AC).
  • G2B groin to brain
  • AC aspiration catheter
  • this terminology is for convenience only and other catheters having different entry points (eg. the radial or brachial artery) are contemplated.
  • FIG. 1B The problem being addressed is shown in Figure 1B, where a surgeon has successfully maneuvered a G2B, MC and MW to the ophthalmic artery and the G2B has become stuck at a position (referenced herein as S) leading into the tortuous section.
  • S a position leading into the tortuous section.
  • a portion of an edge of the distal tip of the G2B will contact the outer curved section of the artery/vessel wall (VW) and will not be able to be pushed around the curve.
  • the MC and MW are shown projecting a short distance from the distal tip of the G2B.
  • the MC and MW may be withdrawn and a combined assembly of a MC, a redirection device (RD) (retained within a different MC) and push wire PW are advanced to the distal tip of the G2B.
  • the RD is designed to be deployed from the end of the MC simply to assist in moving the G2B around the curve as opposed to a stent designed to engage with and withdraw a clot.
  • the MC/RD/PW assembly is pre-assembled such that the redirection is frictionally engaged within the MC at the distal tip of the MC.
  • the PW is connected to the proximal end of the RD and can be pushed/pulled relative to the MC such that the RD can be extended from the MC and withdrawn/re-sheathed back into the MC.
  • the MC/RD/PW assembly is conveyed to the distal tip of the G2B and positioned such that it extends a short distance from the G2B. This distance will typically be between 1-80 mm depending on the ability of the surgeon to navigate this assembly past the G2B. In Figure 1C this is shown as a relatively short distance of a few mm.
  • Figure 1D shows the RD as partially deployed past the G2B. That is, the PW has been held and the MC withdrawn thus partially unsheathing the RD. As shown, the RD is self-expanding and will thus expand to engage with the vessel wall VW as well as the distal tip of the G2B. This expansion and engagement with the G2B will have a tendency to ease the portion of the distal tip of the G2B away from VW at S thus relieving pressure that has caused the G2B to become stuck.
  • the G2B can be pushed forward over the RD thus allowing the G2B to be advanced past S.
  • the RD can then be re-sheathed as shown in Figure 1F by pushing the MC forward.
  • the MC/RD/PW assembly can then be withdrawn and the MC/MW re-introduced to continue advancement of the G2B to the clot Y as shown in Figure 1G.
  • an edge of the G2B has come into contact with an outer surface of the VW preventing further progress.
  • a small gap G may exist between an inner surface of the VW and the G2B.
  • the MC is shown near the distal tip of the G2B and the MW is shown progressing around the tortuous section of the vasculature.
  • Figure 2B shows a mechanism by which the RD may cause deflection of the distal tip of the G2B after it has been deployed from the MC and G2B.
  • the RD (note: any cross-wires of the RD have been excluded for clarity) has been deployed such that it extends around the curve of the tortuous section wherein the self-expanding wires of the RD have deflected the tip of the G2B in a direction F against the inner surface of the vessel thus eliminating the gap G and relieving pressure at S.
  • the G2B can be advanced past S over the RD.
  • the G2B may in some situations be advanced over the RD to a position as shown by the dotted lines in Figure 2B.
  • Figure 2C shows a schematic cross-section of the distal tip of a G2B at line 2C-2C and how the RD (note: any cross wires also not shown for clarity) may deflect the G2B to relieve pressure at S and move the G2B to fill gap G.
  • the dotted lines show the G2B after it has been deflected.
  • FIGS 3A-3F show the deployment of a RD in accordance with an alternate embodiment where the MW, RD and MC are designed to enable simultaneous advancement of a G2B, MW, MC and RD thus enabling fewer steps in the event that the G2B becomes stuck. Moreover, in one embodiment, as discussed below the need for a MC may also be obviated.
  • Figures 3A-3F are drawn for clarity as a projection of a curved section of the vasculature onto a flat surface (see inset of Figure 3A) and, as such, are intended to show the sequence of steps showing the progression of the components of the system through curved sections of the vasculature and the manipulation of the different components relative to one another.
  • a G2B is shown stuck at S.
  • a RD is operatively retained/compressed within a MC and a MW capable of linear movement relative to the RD between two positions is retained within the MS and MC.
  • the MW includes a distal end stop (DES) and proximal end stop (PES) that can operatively engage with a proximal end of the RD to both “push” the MS from the MC and “pull” the RD into the MC.
  • the DES and PES may be positioned approximately 10 cm from one another along the length of the MW and thus enable the MW to move co-axially a distance of Y (eg. 10cm) without engagement with the RD.
  • the DES may be positioned a distance Z (eg. 6-10 cm) from the distal tip of the MW.
  • the surgeon may advance the combined G2B, MW, MC and RD components simultaneously wherein during advancement, the RD is frictionally retained at the distal end of the MC and the MW can be steered and advanced by pushing the MW forward up to the distance Y and then the MC and G2B can be progressively pushed forward over the MW.
  • the PES of the MW may be used to hold the RD at a position forward of the G2B.
  • the MC/RD may be moved forward to a desired position forward of S (shown illustratively as 2-3 cm).
  • the MW PES is positioned proximal to the MS and the MC is withdrawn ( Figure 3C).
  • Figure 3C As shown schematically in Figure 3C, as the RD is deployed and engages with the distal tip of the G2B, this may relieve pressure on the distal tip and allow the G2B to be pushed forward and ride over the RD ( Figure 3D).
  • the RD may then be re-sheathed by moving the MW proximally such that the DES engages with the proximal end of the RD thus holding the MS in position.
  • the RD can be re-sheathed by either pushing the MC forward ( Figure 3E) or pulling the MW proximally.
  • the assembly may be continued to be advanced as shown in Figure 3F.
  • the RD may be non-self- expanding stent, that is, a stent that can be manually manipulated/locked between a collapsed (4A) and expanded (4B) configuration thus giving the surgeon additional control on the application of RD pressure to assist in relieving pressure at S.
  • the RD includes a wire mesh having a push wire PW fixed to the proximal end 20 of the RD and a MW fixed to the distal end 22 of the MS.
  • movement of the PW relative to the MW causes a shortening or lengthening of the distance between the proximal and distal ends of the RD and corresponding expansion or contraction respectively of the diameter D of the MS. That is, in Figure 4B, the PW has been held and the MW pulled proximally so as cause D to expand.
  • the PW and MW may be retained within a PES and MC to ensure coordinated movement and include appropriate external locking/positioning mechanisms (not shown) to limit/control the relative movement and positioning of MW and PW relative to one another.
  • the MW may also be provided with a DES distal and external to the RD that allows for forward movement of the MW relative to the RD so as to enable the MW to be advanced and steered/torqued in the manner as described above.
  • the RD is conveyed distally within the G2B without a MC.
  • the embodiment of Figures 4A and 4B is particularly suited for this method in that the stiffness of the RD can be controlled during advancement. That is, if the MS is being conveyed forward and the MW and PW are positioned in a mid-setting, if the surgeon determines that the system needs to be less stiff, the RD can be lengthened to reduce the stiffness. Similarly, additional stiffness can be introduced by shortening the DES to PES distance.
  • FIGs 5A-5D illustrate deployment of a redirection device RD at a vessel bifurcation where the RD can function both as a RD and clot retrieval system.
  • a clot Y is located at a bifurcation of a vessel with the proximal face of the clot just beyond the bifurcation.
  • An aspiration catheter such as a AC/G2B has been positioned close and proximal to the proximal end of the clot by the manipulation of MWs and MCs as is known but has become stuck where proximal edge of the AC has hit the edge of the bifurcation at S.
  • an RD is deployed as shown in Figures 5B-5D to advance the AC closer.
  • the MC is then withdrawn such that the stent retriever is deployed within the clot where, after a short time to allow the clot to engage with the stent retriever, both the stent retriever and MC can be withdrawn into an aspiration catheter that may be some distance upstream.
  • Figure 5B shows a MC containing an RD that has been positioned as described above. Although not shown in this figure, the RD generally has a greater proportion of longitudinal wires to enable engagement with the clot.
  • Figure 5C shows the MC having been withdrawn to allow the RD to expand and engage with the clot.
  • the MC and RD have been positioned such that the proximal end of the RD is within the AC.
  • the RD, AC and MC are positioned/manipulated in order to exert a force F on the distal tip of the AC to cause it to be redirected away from the bifurcation edge.

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Abstract

L'invention concerne des systèmes de cathéter et des procédés pour accéder au cerveau pendant des procédures endovasculaires et de neurointervention dans le traitement d'un accident vasculaire cérébral ischémique. Plus spécifiquement, l'invention concerne un système de cathéter ayant un dispositif de redirection déployable (RD) qui améliore le processus d'accès à un caillot chez un patient ayant eu un accident ischémique aigu dû à une occlusion d'un grand vaisseau.
PCT/CA2020/051695 2019-12-09 2020-12-09 Systèmes de redirection de cathéter destinés à être utilisés pour accéder à des artères cérébrales WO2021113970A1 (fr)

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US17/293,027 US12194252B2 (en) 2019-12-09 2020-12-09 Catheter redirection systems for use in gaining access to cerebral arteries

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US62/945,432 2019-12-09

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CA3089554A1 (fr) * 2018-01-25 2019-08-01 Ischemicure Ltd. Dispositifs, systemes et procedes pour retirer des caillots sanguins
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US10456552B2 (en) * 2014-07-28 2019-10-29 Mayank Goyal System and methods for intracranial vessel access
US20160030709A1 (en) * 2014-07-30 2016-02-04 Covidien Lp Opening system for improving catheter delivery
CA3089554A1 (fr) * 2018-01-25 2019-08-01 Ischemicure Ltd. Dispositifs, systemes et procedes pour retirer des caillots sanguins
US20200163678A1 (en) * 2018-11-27 2020-05-28 Mg Stroke Analytics Inc. Preloaded Catheter And Clot Retrieval Systems And Methods For Treatment Of Ischemic Stroke

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US11679195B2 (en) 2021-04-27 2023-06-20 Contego Medical, Inc. Thrombus aspiration system and methods for controlling blood loss
US11679194B2 (en) 2021-04-27 2023-06-20 Contego Medical, Inc. Thrombus aspiration system and methods for controlling blood loss
US11717603B2 (en) 2021-04-27 2023-08-08 Contego Medical, Inc. Thrombus aspiration system and methods for controlling blood loss
US11931502B2 (en) 2021-04-27 2024-03-19 Contego Medical, Inc. Thrombus aspiration system and methods for controlling blood loss

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